Dazodalibep for Sjögren's Syndrome

Recruiting at 308 trial locations

Overseen By Amgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Horizon Pharma Ireland, Ltd., Dublin Ireland

Disqualifiers: Thrombosis, Polymyositis, Malignancy, Pregnancy, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

435 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests dazodalibep, a new treatment for individuals with moderate-to-severe Sjögren's Syndrome, an autoimmune disease causing dry mouth, dry eyes, and other symptoms. The main goal is to assess how well dazodalibep reduces these symptoms based on patient reports. The trial also examines the treatment's effects on overall health, saliva production, and safety. Participants will receive either a placebo or one of two doses of dazodalibep through an IV. Suitable candidates have been diagnosed with Sjögren's Syndrome and experience significant symptoms that affect daily life. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that dazodalibep is likely to be safe for humans?

Research has shown that dazodalibep has been tested for safety in people with Sjögren's Syndrome (SS). In earlier studies, patients who took dazodalibep experienced improvements in symptoms such as dryness, tiredness, and pain. These studies also assessed how well participants tolerated the treatment.

Reports indicate that dazodalibep is generally well-tolerated. Most side effects were mild to moderate, and serious side effects were rare. While some individuals might experience minor issues, the treatment is considered safe for most participants.

The trial's advanced stage suggests that earlier tests confirmed its safety, providing confidence in its safety for this trial. For those considering participation, it is reassuring to know that dazodalibep has already undergone several rounds of safety checks. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Sjögren's Syndrome?

Unlike standard treatments for Sjögren's Syndrome, which typically focus on symptom management with medications like artificial tears, corticosteroids, or immunosuppressants, Dazodalibep offers a novel approach. This experimental drug works by targeting a specific pathway in the immune system, potentially reducing the underlying inflammation that causes the symptoms of Sjögren's. Dazodalibep is administered via intravenous infusion, allowing for precise dosing and potentially more effective management of the condition. Researchers are excited because this could lead to more targeted relief for patients, addressing the root causes rather than just alleviating symptoms.

What evidence suggests that dazodalibep might be an effective treatment for Sjögren's Syndrome?

Research has shown that dazodalibep may help improve symptoms in people with Sjögren's Syndrome. Studies have found that patients taking dazodalibep experienced noticeable improvements in dryness, tiredness, and pain, which are main symptoms of the condition. In this trial, participants will receive either one of two doses of dazodalibep or a placebo. Previous studies demonstrated clear benefits of the treatment compared to a placebo. These positive effects suggest that dazodalibep might work by affecting a specific pathway involved in the disease. Overall, these findings offer hope that dazodalibep could be a promising option for managing symptoms of Sjögren's Syndrome. ^{2 4 6 7 8}

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

This trial is for people with Sjögren's Syndrome who have moderate-to-severe symptoms. Participants must meet the 2016 ACR/EULAR criteria, have certain levels of symptom severity scores (ESSPRI ≥ 5 and ESSDAI < 5), test positive for specific autoantibodies, and still produce some saliva. They should be vaccinated against COVID-19 unless they opt out, not have a history of TB or recent exposure to it, and test negative for TB.

Inclusion Criteria

I show no signs or symptoms of active tuberculosis.

I have been diagnosed with Sjögren's syndrome according to the 2016 criteria.

I have been vaccinated against COVID-19 as per local guidelines or have chosen not to be.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dazodalibep or placebo by IV infusion to evaluate efficacy and safety in Sjögren's Syndrome

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dazodalibep

Trial Overview The study tests Dazodalibep's impact on patient-reported symptoms in those with Sjögren's Syndrome versus a placebo. It also looks at how well Dazodalibep improves systemic activity indicators, patient outcomes, and salivary flow. Safety and tolerability after multiple doses are evaluated as secondary objectives.

How Is the Trial Designed?

Group I: Dazodalibep Dose 2 Experimental Treatment 1 Intervention

Participants will be administered dose 2 of dazodalibep by IV infusion.

Group II: Dazodalibep Dose 1 Experimental Treatment 1 Intervention

Participants will be administered dose 1 of dazodalibep by intravenous (IV) infusion.

Group III: Placebo Placebo Group 1 Intervention

Participants will be administered placebo by IV infusion.

Who Is Running the Clinical Trial?

Horizon Pharma Ireland, Ltd., Dublin Ireland

Lead Sponsor

Trials

31

Recruited

3,700+

Amgen

Lead Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Published Research Related to This Trial

Current studies on oral and biologic disease-modifying antirheumatic drugs for Sjögren's syndrome have not shown significant positive outcomes, indicating a need for better treatment options.

Future improvements in trial design, including multicenter studies and standardized measures, along with new drug developments, may enhance the effectiveness of treatments for Sjögren's syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Issues related to clinical trials of oral and biologic disease-modifying agents for Sjögren's syndrome. Carsons, SE.[2013]

Recent advancements in understanding the pathophysiology of Sjögren Syndrome (SS) have led to the development of targeted treatment options, particularly focusing on B-cell targeted therapies, which show promise for managing systemic manifestations of the disease.

While B-cell therapies are currently the most promising, other treatment pathways, including T-cell co-stimulation and cytokine-based therapies, are also being explored, indicating a potential for significant therapeutic advancements in the next decade.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating the Underlying Pathophysiology of Primary Sjögren Syndrome: Recent Advances and Future Prospects. Brito-Zerón, P., Retamozo, S., Gheitasi, H., et al.[2018]

In a study of 15 French patients with primary Sjögren's syndrome, higher baseline levels of natural killer cells were linked to a lack of response to belimumab treatment, suggesting these cells may play a significant role in the disease.

The findings highlight the importance of considering natural killer cell levels when determining treatment strategies for patients, indicating a need for personalized therapy approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stratifying primary Sjögren's syndrome: killers in the balance? Bowman, SJ., Fisher, BA.[2018]

In a study of patients with Primary Sjögren's Syndrome (PSS) using data from the UK Primary Sjögren's Syndrome Registry, it was found that patients with high symptom burden (HSB) and pain dominated fatigue (PDF) had significantly more comorbidities and were prescribed more medications compared to those with low symptom burden (LSB) and dryness dominated fatigue (DDF).

The research indicates that comorbidities and polypharmacy scores increase with age and body mass index (BMI) across all PSS subgroups, suggesting that these factors may complicate disease management and should be considered in clinical trial designs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comorbidities in the UK Primary Sjögren's Syndrome Registry. Tarn, J., Lendrem, D., Barnes, M., et al.[2022]

The EULAR Task Force developed the first evidence-based recommendations for managing Sjögren syndrome (SjS), focusing on symptom relief and addressing dryness, fatigue, and pain, based on a comprehensive review of studies involving primary SjS patients over the last 16 years.

The recommendations include a range of treatment options, from topical therapies like saliva substitutes and artificial tears to systemic medications such as hydroxychloroquine and biological therapies, providing a structured approach for healthcare professionals worldwide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EULAR recommendations for the management of Sjögren's syndrome with topical and systemic therapies. Ramos-Casals, M., Brito-Zerón, P., Bombardieri, S., et al.[2022]

Citations

1. ard.bmj.com ard.bmj.com/content/82/Suppl_1/201

LB0003 Dazodalibep (VIB4920/HZN4920) in Sjögren's ... DAZ-treated subjects experienced a statistically significant and clinically meaningful improvement in the key subjective symptoms of Sjögren's relative to PBO ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003496724635983

OP0143 EFFICACY AND SAFETY OF DAZODALIBEP ... The objective of this study was to evaluate the efficacy and safety of DAZ therapy in adult SS subjects with moderate-to-high systemic disease activity.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04129164

NCT04129164 | A Study to Evaluate the Efficacy and ... The purpose of the study is to evaluate the efficacy, safety, and tolerability of VIB4920 (formerly MEDI4920) in adult participants with Sjögren's Syndrome (SS) ...

4. the-rheumatologist.org the-rheumatologist.org/article/dazodalibep-for-sjogrens-disease/3/

Dazodalibep for Sjögren's Disease - Page 3 of 3 found that patients with Sjögren's disease treated with dazodalibep experienced greater improvement in key symptoms of dryness, fatigue and pain ...

5. nature.com nature.com/articles/s41591-024-03009-3

CD40 ligand antagonist dazodalibep in Sjögren's disease DAZ appears to be a potential new therapy for SjD and its efficacy implies an important role for the CD40/CD40 ligand pathway in its pathogenesis.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06245408

A Safety and Efficacy Study of Dazodalibep in Participants ... Primary Objective: To evaluate the effect of dazodalibep on patient-reported symptoms of SS in participants with moderate-to-severe symptom state.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04129164

A Study to Evaluate the Efficacy and Safety of VIB4920 ... The purpose of the study is to evaluate the efficacy, safety, and tolerability of VIB4920 (formerly MEDI4920) in adult participants with Sjögren's Syndrome (SS) ...

8. amgentrials.com amgentrials.com/study/?id=HZNP-DAZ-303

A Safety and Efficacy Study of Dazodalibep in Participants ... Primary Objective: To evaluate the effect of dazodalibep on patient-reported symptoms of SS in participants with moderate-to-severe symptom state Secondary ...